Clean Transportation System

ABSTRACT

A method of transporting a biological material container between a sterile field and a nonsterile field and substantially maintaining sterility of the biological material container. A first portion with a first end of the container is inserted into an inner cavity of a first member of a housing assembly. A second member of the housing assembly is coupled to the first member such that a second portion of the biological material container is covered by the second member. A second end of the biological material container opposite to the first end is covered with a cap member of the housing assembly such that the biological material container is full encapsulated within the housing assembly to maintain sterility in the nonsterile field. A container port of the biological material container is coupled to a cap port extending through the housing assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/476,587 filed on May 21, 2012, which is a continuation of U.S. patentapplication Ser. No. 12/062,817 filed on Apr. 4, 2008, now U.S. Pat. No.8,182,769 issued on May 22, 2012. The entire disclosures of the aboveapplications are incorporated herein by reference.

FIELD

This invention relates to a sterile biological material container, andmore particularly, to a clean transportation system for a sterilecontainer.

INTRODUCTION

Certain methods and devices have been proposed for maintaining sterilityof biological materials when being transported between sterile andnonsterile fields. For instance, in some cases, blood is obtained in asterile field from a patient and is introduced into a sterile vesselwhere it is protected from contamination. Then, the vessel istransferred to a nonsterile field and is spun in a centrifuge toseparate the components of the blood. Next, a syringe is used toaspirate one or more blood components from the vessel. Subsequently, theblood is aspirated from the syringe into one or more sterile cupslocated inside the sterile field, and one or more of the separatedcomponents is then used depending on the surgical procedure.

However, conventional methods and devices for transporting biologicalmaterials between sterile and nonsterile fields suffer from certaindisadvantages. For instance, in the example discussed above, thesterility of the blood may be compromised, especially when the blood isintroduced to the cups. More specifically, although the cups are locatedin the sterile field, the cups are still somewhat exposed to theenvironment inside the operating room, and contamination may occur.

Furthermore, these conventional methods and devices can be timeconsuming and inconvenient because the fluids are transferred between asubstantial number of vessels. In addition, a substantial amount ofwaste can be produced using these methods because once a vessel is used,it is typically discarded.

SUMMARY

A transportation system for transporting a biological material containerbetween a sterile field and a nonsterile field and substantiallymaintaining sterility of the biological material container is disclosed.The system includes a housing assembly that removably houses thebiological material container. The system also includes a port definedby the housing assembly, and the port provides communication into thebiological material container from outside the housing assembly. Thehousing assembly includes a first member that covers a first portion ofthe biological material container such that a second portion of thebiological material container extends from the first member. The housingassembly also includes a second member that covers the second portion ofthe biological material container. The second member is removablycoupled to the first member to expose the second portion of thebiological material container.

In another aspect, a biological material container system is disclosedthat includes a biological material container having a first portion anda second portion. The system also includes a transportation system fortransporting the biological material container between a sterile fieldand a nonsterile field and substantially maintaining sterility of thebiological material container. The transportation system includes ahousing assembly that removably houses the biological material containerand a port defined by the housing assembly. The port providescommunication into the biological material container from outside thehousing assembly. Also, the housing assembly includes a first memberthat covers a first portion of the biological material container suchthat the second portion of the biological material container extendsfrom the first member. The housing assembly further includes a secondmember that covers the second portion of the biological materialcontainer. The second member is removably coupled to the first member toexpose the second portion of the biological material container forremoval of the biological material container from the first member ofthe housing assembly.

In still another aspect, a method of transporting a biological materialcontainer between a sterile field and a nonsterile field andsubstantially maintaining sterility of the biological material containeris disclosed. The method includes encapsulating the biological materialcontainer within a housing assembly. The housing assembly includes afirst member, a second member removably coupled to the first member, anda port providing communication into the biological material containerfrom outside the housing assembly. The biological material containerincludes a first portion covered by the first member and a secondportion covered by the second member and extending from the firstmember. The method additionally includes introducing a biologicalmaterial into the biological material container via the port andtransporting the biological material container within the housingassembly between the sterile field and the nonsterile field.Furthermore, the method includes decoupling the second member from thefirst member and exposing the second portion of the biological materialcontainer. Moreover, the method includes removing the biologicalmaterial container from the first member via the second portion of thebiological material container.

Furthermore, a transportation system for transporting a biologicalmaterial container for centrifugation in a centrifuge is disclosed. Thetransportation system includes a housing assembly that removably housesthe biological material container to maintain sterility of thebiological material container. The transportation system also includes akeying member that keys the housing assembly in the centrifuge tomaintain a predetermined orientation of the housing assembly in thecentrifuge.

Moreover, a centrifuge system is disclosed that includes a housingassembly that removably houses a biological material container tomaintain sterility of the biological material container. The centrifugesystem also includes a centrifuge with a bucket that receives thehousing assembly. The centrifuge centrifuges the housing assembly andthe biological material container. Also, the centrifuge system includesa keying member that keys the housing assembly in the centrifuge bucketto maintain a predetermined orientation of the housing assembly in thecentrifuge bucket.

Further areas of applicability of the present invention will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the embodiments of the invention, are intended for purposesof illustration only and are not intended to limit the scope of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 is a perspective view of a biological material container systemaccording to teachings of the present disclosure;

FIG. 2 is a perspective exploded view of the biological materialcontainer system showing the system partially disassembled;

FIG. 3 is a perspective view of the biological material container systemshowing the system in a further disassembled state;

FIG. 4 is a perspective view of the biological material container systemshowing the system in a still further disassembled state;

FIG. 5 is a perspective view of the biological material container systemhaving another coupling;

FIG. 6 is a side view of another coupling of the biological materialcontainer system;

FIG. 7 is a perspective view of the biological material container systemhaving still another coupling;

FIG. 8 is a side view of the biological material container systemaccording to another embodiment; and

FIGS. 9A-9C are perspective views of various embodiments of a centrifugesystem with a keying member.

DETAILED DESCRIPTION

The following description of the embodiment(s) is merely exemplary innature and is in no way intended to limit the invention, itsapplication, or uses. Moreover, the container system described herein isdiscussed in association with a biological material container of a typeshown in U.S. Pat. No. 7,179,391, which issued Feb. 20, 2007, U.S.Patent Publication No. 2005/0109716, which was filed on Sep. 2, 2004,and/or U.S. Patent Publication No. 2006/0278588, which was filed on May26, 2006, each of which are incorporated herein by reference. However,it will be appreciated that the container system can be used inassociation with any suitable biological material container withoutdeparting from the scope of the present disclosure.

With initial reference now to FIGS. 1-4, a biological material containersystem 10 is illustrated. The system 10 generally includes a biologicalmaterial container 12 and a transportation system 14. The biologicalmaterial container 12 is removably disposed within the transportationsystem 14. Also, as will be discussed in greater detail, thetransportation system 14 is suitable for transporting the biologicalmaterial container 12 between a sterile field and a nonsterile fieldwhile substantially maintaining sterility of the biological materialcontainer 12.

The biological material container 12 is generally a hollow enclosedcontainer. In some embodiments, the container 12 is generallycylindrical and defines an axis A. Furthermore, the container 12includes at least one port 16 a, 16 b, 16 c. The ports 16 a, 16 b, 16 cprovide fluid communication into and out of the container 12. The ports16 a, 16 b, 16 c can be Luer lock connectors of a male or female type.Furthermore, the ports 16 a, 16 b, 16 c can include an associated cap(not specifically shown) for covering the corresponding ports 16 a, 16b, 16 c.

The container 12 can be used for containing any suitable biologicalmaterial. For instance, in one embodiment, the container 12 is used forholding blood. Furthermore, in some embodiments, the container 12 can beinserted into a centrifuge (not specifically shown) for separating thebiological materials into components of different densities. It will beappreciated that the container 12 could be of any suitable type. In someembodiments, the container 12 is of a type shown in U.S. Pat. No.7,179,391, which issued Feb. 20, 2007, U.S. Patent Publication No.2005/0109716, which was filed on Sep. 2, 2004, and/or U.S. PatentPublication No. 2006/0278588, which was filed on May 26, 2006, each ofwhich are incorporated herein by reference. However, it will beappreciated that the container 12 could be of any other suitable type,including a syringe and the like.

The transportation system 14 generally includes a housing assembly 18that removably houses (i.e., encapsulates) the biological materialcontainer 12 to substantially maintain sterility of the container 12. Insome embodiments, the housing assembly 18 is substantially shapedaccording to an outer shape of the biological material container 12.Also, in some embodiments, the housing assembly 18 is made out of asubstantially rigid material. For instance, in some embodiments, thehousing assembly 18 is made of a relatively rigid polymer and formedusing an injection molding process.

The housing assembly 18 includes a first member 20. The first member 20is substantially tubular in shape and hollow. Furthermore, the firstmember 20 defines an open end 22 (FIG. 4) and a closed bottom end 24.Furthermore, the first member 20 includes a threaded portion 26 (FIGS. 3and 4). The threaded portion 26 is included on an outer surface of thefirst member 20 adjacent the open end 22.

When the container 12 is disposed within the housing assembly 18, thefirst member 20 covers a first portion 28 (FIG. 4) of the container 12.Also, the longitudinal length of the first member 20 is less than thelongitudinal length of the container 12, and as such, a second portion30 and a third portion 32 of the container 12 extend from and protrudeout of the first member 20 of the housing assembly 18.

The housing assembly 18 further includes a second member 34. In someembodiments, the second member 34 is generally ring shaped so as todefine a first open end 36 and a second open end 38.

The second member 34 also includes a plurality of hollow side members 40a, 40 b. The side members 40 a, 40 b are substantially box shaped andinclude a plurality of side walls 42 and a bottom wall 44. The sidemembers 40 a, 40 b also define an open top end 46. As shown in FIG. 2,the side members 40 a, 40 b each receive and accommodate a correspondingport 16 b, 16 c of the biological material container 12. Furthermore,the side members 40 a, 40 b can improve gripping and/or disassembly ofthe housing assembly 18 as will be described in greater detail below.

The second member 34 can also include a threaded portion 48. Thethreaded portion 48 can be included on an inner surface of the secondmember 34 adjacent the second open end 38.

As shown in FIGS. 3 and 4, the second member 34 slides over the firstmember 20 along the axis A. Furthermore, the threaded portion 48 of thesecond member 34 threadably engages with the threaded portion 26 of thefirst member 20. As such, the threaded portions 26, 48 comprise athreaded coupling member with which the second member 34 is removablycoupled to the first member 20. In other words, when the second member34 is threadably engaged with the first member 20, the second member 34surrounds the first member 20 adjacent the open end 22 of the firstmember 20. Also, the second member 34 can threadably disengage from thefirst member 20 and slide away from the open end 22 along the axis A toexpose the second portion 30 of the biological material container 12.

The housing assembly 18 additionally includes a cap member 50 (FIGS. 1and 2). The cap member 50 is substantially disk shaped and flat. The capmember 50 includes a main body portion 52, a plurality of wings 54 a, 54b and a plurality of tabs 56. In some embodiments, the main body portion52, the wings 54 a, 54 b, and the tabs 56 are each integrally coupled.The cap member 50 is removably coupled to the second member 34 so as tocover the first open end 36 of the second member 34 and maintain thecontainer 12 in a sterile condition.

In some embodiments, the cap member 50 is removably coupled to thesecond member 34, via a friction fit. More specifically, in someembodiments, the cap member 50 includes a recessed bottom surface 58(FIG. 2) that is frictionally received in the first open end 36 of thesecond member 34. When coupled to the second member 34, the wings 54 a,54 b extend over and cover the open ends 46 of the side members 40 a, 40b, and the main body portion 52 substantially covers the remainingportions of the first open end 36.

Furthermore, the tabs 56 extend away from the axis A and outward fromthe second member 34. As will be explained, the tabs 56 enable removalof the cap member 50 from the housing assembly 18.

Additionally, when the cap member 50 is coupled to the second member 34,the cap member 50 substantially covers the third portion 32 of thebiological material container 12.

The housing assembly 18 additionally defines a port 60 (FIGS. 1 and 2).In some embodiments, the port 60 is defined by the cap member 50. Also,in some embodiments, the port 60 is Luer lock connector of a male orfemale type. In some embodiments, the cap member 50 also includes a stem(not specifically shown) that is in fluid communication with the port60, extends from the bottom surface 58, and is received within the port16 a of the biological material container 12. As such, the port 60provides fluid communication with the port 16 a of the container 12, andas will be explained, the port 60 provides communication into thebiological material container 12 from outside the housing assembly 18.

Furthermore, the housing assembly 18 can include a port cover 62 (FIGS.1 and 2). The port cover 62 is removably coupled to the port 60. Theport cover 62 can be of a male or female type. The port cover 62 canalso include a threaded cap that threads onto the port 60 and a separateplug (not specifically shown) that blocks the port 60 and maintainssterility in the housing assembly 18.

With reference now to FIGS. 1-4, assembly and disassembly of thebiological material container system 10 will be discussed in greaterdetail. In some embodiments, the biological material container 12 issterilized (e.g., by gamma radiation, in an autoclave, etc.), and theinterior surfaces of the housing assembly 18 are also sterilized (e.g.,by gamma radiation, in an autoclave, etc.). The container 12 is theninserted into the housing assembly 18 substantially as represented inFIG. 1. Also, in some embodiments, the container 12 is inserted into thehousing assembly 18 as represented in FIG. 1, and the entire assembly issterilized as one unit in any suitable manner (e.g., gamma radiation, inan autoclave, etc.) It will be appreciated that the biological materialcontainer system 10 can be packaged and sold as a sterile unitsubstantially as represented in FIG. 1. It will also be appreciated thatthe individual components can be sterilized and assembled by theconsumer.

For purposes of the following discussion, it is assumed that thebiological material container system 10 is assembled as represented inFIG. 1. It is also assumed that the biological material container 12 andthe interior of the housing assembly 18 have been sterilized.

Initially, the port cover 62 is removed from the port 60, and blood orother biological material is introduced into the biological materialcontainer 12 through the ports 60, 16 a. The container 12 and thehousing assembly 18 can include a vent (e.g., a hydrophobic vent) toallow pressure to equalize as the biological material is introduced intothe biological material container 12. Once the biological material hasbeen introduced, the port cover 62 is re-coupled to the port 60. Thiscan be performed inside or outside a sterile field.

More specifically, in some embodiments, an initial port cover 62 isremoved and discarded, the biological material is introduced into thebiological material container 12, and a new, sterile, replacement portcover 62 is coupled to the port 60. In some embodiments, the replacementport cover 62 is separately packaged or tethered to the housing assembly18.

Furthermore, in some embodiments, the initial port cover 62 is removed,leaving a plug (not specifically shown) in the port 60. When it is timeto introduce the biological material into the container 12, the plug isremoved, and the biological material is introduced into the container12. Then, a new replacement port cover 62 is coupled to the port 60.

Once the port cover 62 has been replaced, the biological materialcontainer system 10 can be moved (e.g., by a circulating nurse, etc.) toa nonsterile field for processing. In some embodiments, the biologicalmaterial container system 10 is inserted into a centrifuge machine (notspecifically shown), and the biological material in the container 12 iscentrifuged to separate the components of the biological material. Itwill be appreciated that the container 12 remains substantially encasedwithin the housing assembly 18 to substantially maintain sterility ofthe container 12 and the biological material within the container 12. Assuch, the centrifuge need not be sterilized before centrifuging thecontainer 12.

Then, the biological material container system 10 can be moved to asterile field (e.g., by the circulating nurse, etc.), and the nonsterilepersonnel (e.g., the circulating nurse, etc.) can disassemble thehousing assembly 18 and expose the biological material container 12 forremoval by sterile personnel (e.g., a scrub tech, etc.).

More specifically, in order to disassemble the housing assembly 18, thenonsterile personnel (e.g., the circulating nurse, etc.) holds onto thefirst member 20 and pushes up on the tabs 56 to move the cap member 50in an axial direction along the axis A away from the second member 34.Next, the nonsterile personnel unthreads and decouples the second member34 from the first member 20 by rotating the second member 34 about theaxis A. In some embodiments, the threading of the threaded portions 26,48 allows the second member 34 to be unthreaded from the first member 20with about one quarter to about one-half of a full turn about the axisA; however, it will be appreciated that the threaded portions 26, 48 canhave any suitable threading to allow the components to separate afterany suitable amount of turning.

Once the second member 34 is threadably disengaged, the nonsterilepersonnel slides the second member 34 away from the open end 22 of thefirst member 20 along the axis A. This exposes the second portion 30 ofthe container 12 that protrudes from the open end 22. As such, sterilepersonnel (e.g., the scrub tech, etc.) is able to grasp the exposedsecond portion 30 of the container 12 and pull the container 12 out ofthe first member 20 along the axis A. It will be appreciated that thisprocess substantially ensures that the container 12 and the biologicalmaterial inside the container 12 remain sterile and uncontaminated.

Referring now to FIGS. 5-7, various alternative embodiments of thecoupling member removably coupling the second member 34 and the firstmember 20 will be described. It will be appreciated that the couplingmembers shown in FIGS. 5-7 can be used in addition to or as analternative to the threaded coupling member shown in FIGS. 1-4.

In FIG. 5, the coupling member removably coupling the second member 34′and the first member 20′ is a bayonet coupling, generally indicated at70. More specifically, the first member 20′ includes a post 72 thatextends outward from the axis A. Furthermore, the second member 34′includes a slot 74 with a first portion 76 that extends generally alongthe axis A from the first open end 36′ of the second member 34′. Theslot 74 also includes a second portion 78 that extends in acircumferential direction adjacent the second open end 38′ of the secondmember 34′. In order to disengage the second member 34′ from the firstmember 20′, the second member 34′ is rotated about the axis A until thepost 72 enters the first portion 76 of the slot 74, and then the secondmember 34′ slides over the first member 20′ along the axis A until thepost 72 is removed from the slot 74. It will be appreciated that thepost 72 could be included on the second member 34′, and the slot 74could be included on the first member 20′ without departing from thescope of the present disclosure. Furthermore, it will be appreciatedthat the cap member 50 (not specifically shown) can be configured tosubstantially cover the slot 74 to substantially maintain sterility ofthe container 12 and the interior of the housing assembly 18′.Additionally, the slot 74 could be embedded within the second member 34′such that the slot 34′ is open only to the interior of the second member34′ and such that the post 72 extends only partially into the secondmember 34′.

In FIG. 6, the first member 20″ includes a post 80 that extends outwardradially from the axis A. The second member 34″ includes a correspondingslot 82 that extends substantially parallel to the axis A. The slot 82includes a protrusion 84 that extends partially into the slot 82generally in a circumferential direction about the axis A. The post 80is removably retained within the slot 82. In other words, in order toremove the second member 34″ from the first member 20″, the secondmember 34″ slides along the axis A away from the open end 22″ of thefirst member 20″, and the second member 34″ deflects, thereby allowingthe post 80 to pass the protrusion 84 and move out of the slot 82. Toengage the first and second member 20″, 34″, the second member 34″slides along the axis A toward the open end 22″ until the post 80 entersthe slot 82. Further movement of the second member 34″ in this directioncauses the second member 34″ to deflect, thereby allowing the post 80 topass the protrusion 84 and be retained in the slot 82 by the protrusion84. It will be appreciated that the housing assembly 18″ can include anynumber of posts 80 and slot 82 combinations.

In FIG. 7, the coupling member removably coupling the second member 34″′to the first member 20″′ includes a plurality of breakable bondedcouplings 90. In some embodiments, the breakable bonded couplings 90 areheat stakes that bond the interior surface of the second member 34″′ andthe exterior surface of the first member 20″′ in localized areas. Itwill be appreciated that the breakable bonded couplings 90 could beincluded at any suitable location, and the housing assembly 18″′ couldinclude any number of breakable bonded couplings 90.

Referring now to FIG. 8, another embodiment of the biological materialcontainer system 10″″ will be discussed. In this embodiment, the housingassembly 18″″ includes a hollow member 92. In some embodiments, thehollow member 92 is substantially cylindrical and hollow and includes anopen top end 94. The hollow member 92 also includes side members 40 a″″,40 b″″ substantially similar to the side members 40 a, 40 b describedabove in relation to FIGS. 1-4. The side members 40 a″″, 40 b″ receiveand accommodate the ports 16 b, 16 c of the biological materialcontainer 12.

The housing assembly 18″″ also includes a cap member 50″″ that isremovably coupled to the hollow member 92 adjacent the open end 94. Insome embodiments, the cap member 50″″ is frictionally coupled to thehollow member 92 (i.e., a frictional fitted coupling removably couplesthe cap member 50″″ and the hollow member 92. The cap member 50″″defines the port 60″″.

The port 60″″ includes an outer portion 96 and a stem 98, which are influid communication with each other. The stem 98 removably couples tothe port 16 a of the biological material container 12. In someembodiments, the stem 98 extends into and frictionally couples to theport 16 a; however, it will be appreciated that the stem 98 can coupleto the port 16 a in any other suitable manner.

When assembled, the cap member 50″″ covers a first portion 97 of thebiological material container 12. Also, the hollow member 92 covers asecond portion 99 of the biological material container 12.

To disassemble the system 10″″, non-sterile personnel (e.g., thecirculating nurse, etc.) removes the hollow member 92 from the capmember 50″″ and moves the hollow member 92 along the axis A away fromthe cap member 50″″. This, in turn, exposes the second portion 99 of thebiological material container 12. Also, the biological materialcontainer 12 extends from and remains coupled to the cap member 50″″,thereby allowing the non-sterile personnel to support the biologicalmaterial container 12 by holding the cap 50″″. The sterile personnel(e.g., the scrub nurse) is then able to grasp the second portion 99 ofthe biological material container 12 and remove the container 12 fromthe cap member 50″″.

It will be appreciated that biological material container system 10,10′, 10″, 10″′, 10″″ provides a useful, convenient, and effective meansof maintain sterility of the biological material container 12 and thebiological materials therein. The housing assembly 18, 18′, 18″, 18″′,18″″ can be easily handled and transported between a sterile and anonsterile field, and can be quickly and easily disassembled to exposethe container 12 for removal from the housing assembly 18, 18′, 18″,18″′, 18″″. Moreover, the housing assembly 18, 18′, 18″, 18″′, 18″″ canbe reused and re-sterilized for use with a plurality of biologicalmaterial containers 12. More specifically, the housing assembly 18, 18′,18″, 18″′, 18″″ can be disassembled and reassembled repeatedly (e.g.,through the frictional fittings, the threaded couplings, the bayonetcouplings, and the slotted couplings, etc.) for added convenience. Itwill be appreciated, however, that the housing assembly 18, 18′, 18″,18″′, 18″′ can be disposable along with the container 12.

Referring now to FIG. 9A-9C, a centrifuge system 100 is illustrated. Thecentrifuge system 100 allows the biological material container system10, 10′, 10″, 10″′, 10″′ to be centrifuged in a sterile manner. Thecentrifuge system 100 can be used in association with any of thebiological material container systems 10, 10′, 10″, 10″′, 10″″ disclosedabove or any other suitable biological material container system. Forpurposes of discussion, however, the centrifuge system 100 will bediscussed in relation to the biological material container system 10 ofFIGS. 1-4.

In the embodiments represented in FIG. 9A, the centrifuge system 100includes a centrifuge 102 with a bucket 104 that receives the biologicalmaterial container system 10. More specifically, the bucket 104 definesa pocket 105 into which the biological material container system 10 canbe disposed. In some embodiments, the pocket 105 is substantiallycylindrical and substantially conforms to the outer shape of thebiological material container system 10.

The centrifuge system 100 also includes a keying member 106 thatmaintains a predetermined orientation of the biological container system10 in the pocket 105. In the embodiments represented in FIG. 9A, thekeying member 106 includes a projection 107 that is included on a bottomsurface 108 of the pocket 105 and a corresponding recess 109 that isincluded on the bottom end 24 of the first member 20 of the housingassembly 18. As shown, the projection 107 and the recess 109 have anelongate shape (e.g., a linear elongate shape) that extendssubstantially transverse to the longitudinal axis A of the biologicalmaterial container system 10. The recess 109 receives the projection 107when the housing assembly 18 is inserted into the pocket 105. Also, whenthe housing assembly 18 is removed from the pocket 105, the bottom end24 is sufficiently flat and large enough such that the housing assembly18 can be set on and be supported by the bottom end 24.

FIGS. 9B and 9C represent other embodiments of the keying member 106′,106″. In the embodiments represented in FIG. 9B, the keying member 106′includes a projection 107′ and a recess 109′, each having a cylindricalshape. Furthermore, in the embodiments represented in FIG. 9C, thekeying member 106″ includes a plurality of projections 107″ and aplurality of corresponding recesses 109″, each having a cylindricalshape.

In each of the embodiments represented in FIGS. 9A-9C, the keyingmembers 106, 106′, 106″ are at least partially offset from thelongitudinal axis A of the biological material container system 10. Morespecifically, in the embodiments represented in FIG. 9A, the elongateshape of the projection 107 and recess 109 extends transversely awayfrom the axis A such that the ends of the projection 107 and recess 109are offset from the axis A. Also, in the embodiments represented in FIG.9B, the projection 107′ and recess 109′ are disposed at a distance fromthe longitudinal axis A. Furthermore, in the embodiments represented inFIG. 9C, one of the projections 107″ and recesses 109″ is disposed onthe axis A, and the other projection 107″ and recess 109″ is disposed ata distance from the longitudinal axis A.

Accordingly, the biological material container system 10 can be insertedinto the pocket 105, and the keying member 106, 106′, 106″ keys andsubstantially limits movement of the biological material containersystem 10 against rotation about the longitudinal axis A. As such, itcan be ensured that the biological material container system 10 isproperly positioned in the pocket 105 of the centrifuge 102 in apredetermined position. In some embodiments, the keying member 106,106′, 106″ can be configured to ensure proper centrifuging of thebiological materials in the biological material container system 10.Also, it will be appreciated that the keying member 106, 106′, 106″ensures that the biological container system 10 will remain in thispredetermined position. Accordingly, the biological material containersystem 10 is less likely to become unbalanced during centrifuging.

It will be appreciated that the keying member 106, 106′, 106″ can be ofany suitable shape and configuration other than those illustrated inFIGS. 9A-9C. For instance, the projections 107, 107′, 107″ can beincluded on the biological material container system 10 and the recesses109, 109′, 109″ can be included on the centrifuge 102. Also, the keyingmember 106, 106′, 106″ can have any suitable shape and can be includedon any suitable surface of the centrifuge 102 and biological materialcontainer system 10.

Moreover, the keying member 106, 106′, 106″ can be configured such thatthe overall shape of the pocket 105 corresponds to the overall shape ofthe biological material container system 10 and inhibits rotation aboutthe axis A. For instance, the pocket 105 could be shaped so as to haveflat surfaces that abut against the side members 40 a, 40 b (FIG. 1-4)to inhibit rotation about the axis A. Also, the pocket 105 could have anoverall shape having flat surfaces that abut against corresponding flatsurfaces of the biological material container system 10 to key thebiological material container system 10 in the pocket 105.

Moreover a plurality of buckets 104 could be provided, each with pockets105 of unique shapes (e.g., rectangular, ovate, etc.), and a pluralityof biological material container systems 10 could be provided, eachhaving corresponding unique shapes. The biological material containersystems 10 would only fit in pockets 105 having the corresponding shape.This would serve to differentiate the biological material containersystems 10 for convenient identification thereof.

Furthermore, the foregoing discussion discloses and describes merelyexemplary embodiments of the present disclosure. One skilled in the artwill readily recognize from such discussion, and from the accompanyingdrawings and claims, that various changes, modifications and variationsmay be made therein without departing from the spirit and scope of thedisclosure as defined in the following claims.

What is claimed is:
 1. A method of transporting a biological materialcontainer between a sterile field and a nonsterile field andsubstantially maintaining sterility of the biological materialcontainer, the method comprising: encapsulating the biological materialcontainer within a housing assembly, the housing assembly including afirst member, a second member removably coupled to the first member, anda port providing communication into the biological material containerfrom outside the housing assembly, the biological material containerincluding a first portion covered by the first member and a secondportion covered by the second member and extending from the firstmember; introducing a biological material into the biological materialcontainer via the port; transporting the biological material containerwithin the housing assembly between the sterile field and the nonsterilefield; decoupling the second member from the first member; exposing thesecond portion of the biological material container; and removing thebiological material container from the first member via the secondportion of the biological material container.
 2. The method of claim 1,further comprising removing a cap member from the housing assembly toexpose a third portion of the biological material container.
 3. Themethod of claim 1, further comprising decoupling the second member fromthe first member and removing the biological material container from thesecond member while the biological material container is coupled to thefirst member.
 4. The method of claim 3, wherein decoupling the secondmember from the first member comprises breaking a frangible couplingbetween the first and second members.
 5. The method of claim 3, whereindecoupling the second member from the first member comprises sliding thesecond member relative the first member and away from the port.
 6. Themethod of claim 1, further comprising accommodating side ports of thebiological material container in side members extending from a first endof the second member.
 7. The method of claim 1, further comprisingfrictionally coupling a cap member to the second member.
 8. A method oftransporting a biological material container between a sterile field anda nonsterile field and substantially maintaining sterility of thebiological material container, the method comprising: inserting a firstportion and a first end of the biological material container into aninner cavity of a first member of a housing assembly, the inner cavityformed between an open end and a closed end of the first member;coupling a second member of the housing assembly to the first membersuch that a second portion of the biological material container iscovered by the second member; covering a second end of the biologicalmaterial container opposite to the first end with a cap member of thehousing assembly such that the biological material container is fullyencapsulated within the housing assembly to maintain sterility in thenonsterile field; and coupling a container port of the biologicalmaterial container to a cap port extending through the housing assembly.9. The method of claim 8, further comprising: introducing a biologicalmaterial into the biological material container via the container port;transporting the biological material container within the housingassembly between the sterile field and the nonsterile field; decouplingthe second member from the first member; exposing the second portion ofthe biological material container; and removing the biological materialcontainer from the first member via the second portion of the biologicalmaterial container.
 10. The method of claim 9, further comprisingsliding the second member relative to the first member away from thecontainer port to decouple the second member from the first member. 11.The method of claim 9, wherein decoupling the second member from thefirst member comprises breaking a frangible coupling between the firstand second members.
 12. The method of claim 9, further comprisingremoving the cap member before decoupling the second member from thefirst member.
 13. The method of claim 12, wherein removing the capmember comprises pulling opposite tabs of the cap member away from thesecond member.
 14. The method of claim 8, further comprisingaccommodating side ports of the biological material container in sidemembers extending from a first end of the second member.
 15. The methodof claim 8, further comprising frictionally coupling the cap member tothe second member.
 16. A method of transporting a biological materialcontainer between a sterile field and a nonsterile field andsubstantially maintaining sterility of the biological materialcontainer, the method comprising: inserting a first end of thebiological material container into an inner cavity of a hollow member ofa housing assembly, the inner cavity formed between an open end and aclosed end of the hollow member; covering a second end of the biologicalmaterial container opposite to the first end with a cap member of thehousing assembly such that the biological material container is fullyencapsulated within the housing assembly to maintain sterility in thenonsterile field; and coupling a container port of the biologicalmaterial container to a cap port extending through the housing assembly.17. The method of claim 16, further comprising: transporting thebiological material container within the housing assembly between thesterile field and the nonsterile field; decoupling the cap member fromthe hollow member; and removing the hollow member from the biologicalmaterial container.
 18. The method of claim 16, further comprising:covering a first portion of the biological material container with thecap member; and covering a second portion of the biological materialcontainer with the hollow member.
 19. The method of claim 16, furthercomprising accommodating side ports of the biological material containerin side members extending from the open end of the hollow member. 20.The method of claim 16, further comprising frictionally coupling the capmember to the hollow member.
 21. A method of transporting a biologicalmaterial container between a sterile field and a nonsterile field andsubstantially maintaining sterility of the biological materialcontainer, the method comprising: transporting a biological materialcontainer fully encapsulated within a housing assembly between thesterile field and the nonsterile field; decoupling a second member ofthe housing assembly from a first member of the housing assembly,wherein the first member covers a first portion of the biologicalmaterial container and the second member covers a second portion of thebiological material container; exposing the second portion of thebiological material container; and removing the biological materialcontainer from the first member via the second portion of the biologicalmaterial container.
 22. The method of claim 21, further comprisingsliding the second member relative to the first member away from a portof the biological material container communicating with the housingassembly to decouple the second member from the first member.
 23. Themethod of claim 21, wherein decoupling the second member from the firstmember comprises breaking a frangible coupling between the first andsecond members.
 24. The method of claim 21, further comprising removinga cap member fully encapsulating the biological material within thehousing assembly before decoupling the second member from the firstmember.
 25. The method of claim 24, wherein removing the cap membercomprises pulling opposite tabs of the cap member away from the secondmember.